Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

Seagen

Status and phase: Terminated; Phase 2

Conditions: Transformed Lymphoma / DLBCL; Diffuse, Large B-Cell, Lymphoma; Follicular Lymphoma, Grade 3b

Treatments: Drug: prednisone; Drug: denintuzumab mafodotin; Drug: rituximab; Drug: doxorubicin; Drug: cyclophosphamide; Drug: vincristine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02855359

SGN19A-004

Details and patient eligibility

About

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

Full description

In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;

  • patients must have high intermediate or high risk disease

• Tumor tissue available from most recent biopsy to determine cell of origin

• Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter

• Eastern Cooperative Oncology Group performance status ≤2

• Age 18 years or older

• Adequate study baseline laboratory parameters

Exclusion criteria

• Previous history of treated indolent lymphoma
• History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
• History of progressive multifocal leukoencephalopathy
• Cerebral/meningeal disease related to the underlying malignancy
• Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

denintuzumab mafodotin + RCHOP

Experimental group

Description:

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Treatment:

Drug: rituximab

Drug: vincristine

Drug: cyclophosphamide

Drug: doxorubicin

Drug: prednisone

Drug: denintuzumab mafodotin

denintuzumab mafodotin + RCHP

Experimental group

Description:

Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)

Treatment:

Drug: rituximab

Drug: cyclophosphamide

Drug: doxorubicin

Drug: prednisone

Drug: denintuzumab mafodotin

denintuzumab mafodotin + RCHOP or RCHP

Experimental group

Description:

Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP

Treatment:

Drug: rituximab

Drug: vincristine

Drug: cyclophosphamide

Drug: doxorubicin

Drug: prednisone

Drug: denintuzumab mafodotin

RCHOP

Active Comparator group

Description:

Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

Treatment:

Drug: rituximab

Drug: vincristine

Drug: cyclophosphamide

Drug: doxorubicin

Drug: prednisone